Anti-CD19 CAR-T Cell Therapy for Patients With Refractory Systemic Lupus Erythematosus (NCT07720310) | Clinical Trial Compass
By InvitationNot Applicable
Anti-CD19 CAR-T Cell Therapy for Patients With Refractory Systemic Lupus Erythematosus
Belarus12 participantsStarted 2026-03-09
Plain-language summary
Systemic lupus erythematosus (SLE) is a chronic autoimmune disease characterized by B-cell dysfunction leading to the production of autoantibodies that play a key role in the onset and progression of the disease. In the treatment of SLE today, glucocorticosteroid hormones, cytostatics (azathioprine, cyclophosphamide, mycophenolate mofetil, hydroxychloroquine, etc.), and biological therapy (rituximab, belimumab) are widely used. However, this therapy has limitations: firstly, it does not always control the autoimmune process and, secondly, it has side effects. Recent global data on the use of CAR T cells in patients with SLE show promising results, including rapid and durable remission, without the need for disease-modifying drugs and glucocorticoids. The use of the so-called academic CAR-T cell products can improve availability and affordability of this therapy option. The aim of this clinical study is to evaluate the efficacy and safety of academic CAR-T cells in refractory SLE patients.
Who can participate
Age range
18 Years – 70 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. A confirmed diagnosis of SLE according to the 2019 EULAR/ACR criteria.
. Subacute or acute SLE.
. SLE activity according to the SELENA-SLEDAI disease activity index screening score ≥6 and/or the requirement for prednisolone (or equivalent doses of methylprednisolone) at a dose greater than 7.5 mg/day (6 mg/day for methylprednisolone) to maintain lower disease activity.
. A history of two or more prior therapies (one of the drugs mycophenolate mofetil or cyclophosphamide, or the development of side effects/intolerance to these drugs).
. Patients aged 18 years or older.
. A medical consultation on the need for this treatment method using cell therapy.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SELENA-SLEDAI activity index assessment and serologic remission (defined as normal level of primary (dsDNA and/or antiSm) and antiphospholipid antibodies (lupus anticoagulant (LA), AT to cardiolipinanti-dsDNA and normal complement C3 and C4 levels)